MANCOR: Corifollitropin Alfa Versus Daily rFSH in the Controlled Ovarian Stimulation of Poor Responders

Sponsor

IVI Sevilla (Other)

Overall Status

Terminated

CT.gov ID

NCT02254928

Collaborator

Instituto Valenciano de Infertilidad, IVI VALENCIA (Other), IVI Madrid (Other), IVI Barcelona (Other)

Enrollment

Locations

Arms

Duration (Months)

6.5

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A randomised, crossover, multicentre, national, clinical trial comparing the efficacy of corifollitropin alfa versus daily recombinant FSH and HMG in the controlled ovarian stimulation of women with a poor ovarian response undergoing IVF treatments. The main objective of this study is comparing the number of oocytes obtained after the follicle puncture when using each of these two stimulation protocols. Only poor responders according to the Bologna criteria will be recruited for this trial. All participants will undergo two stimulation cycles to obtain and accumulate oocytes by vitrification. One of the cycles will be done with the corifollitropin alfa protocol and the other with daily rFSH and HMG, the order of application of these protocols will be randomised (crossover clinical trial) in each patient.

Condition or Disease	Intervention/Treatment	Phase
Infertility	Drug: Corifollitropin alfa	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

26 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Comparative Study Between the Use of Corifollitropin Alfa and Daily Recombinant FSH in the Controlled Ovarian Stimulation of Poor Responders

Study Start Date :

Sep 1, 2014

Actual Primary Completion Date :

Jul 1, 2015

Actual Study Completion Date :

Nov 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Other: Group 1 First stimulation cycle with corifollitropin alfa (experimental) Second stimulation cycle with rFSH and HMG (active comparator)	Drug: Corifollitropin alfa One dose of 150 μg of corifollitropin alfa will be administered at day 1 of stimulation. Stimulation will be continued with 250-300 IU/day of rFSH from day 8 forward. Other Names: Elonva
Other: Group 2 First stimulation cycle with rFSH and HMG (active comparator) Second stimulation cycle with corifollitropin alfa (experimental)	Drug: Corifollitropin alfa One dose of 150 μg of corifollitropin alfa will be administered at day 1 of stimulation. Stimulation will be continued with 250-300 IU/day of rFSH from day 8 forward. Other Names: Elonva

Arm

Intervention/Treatment

Other: Group 1

First stimulation cycle with corifollitropin alfa (experimental) Second stimulation cycle with rFSH and HMG (active comparator)

Drug: Corifollitropin alfa

One dose of 150 μg of corifollitropin alfa will be administered at day 1 of stimulation. Stimulation will be continued with 250-300 IU/day of rFSH from day 8 forward.

Other Names:

Elonva

Other: Group 2

First stimulation cycle with rFSH and HMG (active comparator) Second stimulation cycle with corifollitropin alfa (experimental)

Drug: Corifollitropin alfa

One dose of 150 μg of corifollitropin alfa will be administered at day 1 of stimulation. Stimulation will be continued with 250-300 IU/day of rFSH from day 8 forward.

Other Names:

Elonva

Outcome Measures

Primary Outcome Measures

Number of mature oocytes (metaphase II) [1 year]
Number of mature oocytes (metaphase II) obtained after the follicle puncture

Secondary Outcome Measures

Total number of oocytes [1 year]
Total number of oocytes obtained after the follicle puncture
Symptoms associated with the ovarian stimulation protocol [1 year]
Patients will evaluate their symptoms using a questionnaire. They will score the intensity (from 1 to 10) of each of the following symptoms: pelvic pain, headache, mood swings, nausea, tiredness, breast pain.
Patient perception of the stimulation treatment [1 year]
Patients will evaluate how they have perceived the stimulation treatment using a questionnaire. They will score their comfort (from 1 to 10) with the following aspects of the treatment: treatment administration, number of injections and treatment length.
Length of the stimulation treatment [1 year]
Days of stimulation treatment
Number of subcutaneous injections [1 year]
Number of subcutaneous injections of gonadotropins (corifollitropin alfa, rFSH and HMG)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Advanced maternal age (≥40 years)
A previous poor ovarian response (≤3 oocytes with a conventional stimulation protocol)
An abnormal ovarian reserve test (i.e. antral follicle count <5-7 follicles or anti-mullerian hormone level <0.5-1.1 ng/ml)